Class Class II
BTL-398 (K241516)
Description
BTL-398 by BTL Industries, Inc., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241516
Clearance Date2025-02-10
Clearance TypeTraditional
Product CodeKPI
Regulation Number876.5320
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241516
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BTL-398 (K241516) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181497 | HPM-6000UF | BTL Industries, Inc. | 2018 |
Trace the full predicate network for K241516
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.